Manager QA Design

The conviction that “it must be possible” has been the driving force behind HemoCue for over 35 years, because when it comes to caring for people, we refuse to compromise. We take pride in being a global leader in near-patient, or point‐of‐care, testing where the patient meets the healthcare system for the first time and where accurate, reliable, and fast decisions need to be made. Our culture of positivity, engagement, and a dedication to getting it right will allow you to achieve something remarkable. Join a team where making the impossible possible has become the standard!
HemoCue is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we’re working at the pace of change to improve patient lives with diagnostic tools that address the world’s biggest health challenges.
Do you want to make a difference by developing key lifesaving medical device products? In a truly global business who refuse to compromise when it comes to caring for people.
The Manager QA Design is responsible to lead and build the Quality Assurance Design team along with supporting Product Development and Life Cycle processes including design controls, quality planning, risk assessments/analysis/management, design reviews, approval of test methods, design and process verification and validation test plans and reports. You will be working in close cooperation with different departments and teams across the company. Together with your team you are one part of making sure that we develop and manufacture safe, reliable and compliant products. You will report to Senior Director RAQA.
We offer you an exciting possibility to join our fantastic team creating tomorrow’s solutions for Point of Care testing making peoples life’s better.
In this role, you will have the opportunity to:
Manage and prioritize activities, resources and ensure trained and engaged personnel within the Quality Assurance Design team
Collaborating closely with stakeholders to assure high quality throughout the product development process including design transfer and post launch activities
Ensure compliant and efficient procedures for defined areas of responsibilities, such as Risk Management
Lead Auditor for QMS system

The essential requirements of the job include:
University degree in Science or Technology
Minimum 5 years of experience from Quality and Regulatory Management within Medical device industry
Minimum 3 years of management experience or proven leadership personality
Proven good knowledge (experience or external training) in EU IVD Regulation, ISO 13485, US Quality System Regulation, ISO 14971
Strong skills in cross functional collaboration
English – fluent verbally and in writing, and preferable Swedish/Scandinavian

To be successful in this position we believe you are a great teammate, empathic, team-oriented and proactive and someone who likes a fast pace. You find it easy to communicate with other people and enjoy working in an organization that is motivated by continuous improvement, both in terms of solutions and processes.
At HemoCue we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, hybrid working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a hybrid work arrangement in which you can work part-time at the Company location identified above and part-time remotely from your home. Additional information about this hybrid work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for HemoCue can provide.
Please apply in English by upload your CV and personal letter. In accordance with our GDPR policy we are deleting all applications once the position has been filled.
Applications will be processed as we receive them, and the position might be filled before the last day of application. Don't miss the opportunity, apply today!
For further information, please contact Senior Director RAQA, Maria Fagerberg +46 734 14 03 46.
Union contacts: Björn Bylander, Unionen, +46 431 48 12 87 or Emma Kriblad, Akademikerföreningen, +46 431 48 14 21.
When you join us, you’ll also be joining Danaher’s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.
At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.
If you’ve ever wondered what’s within you, there’s no better time to find out.